Reported Oct 23, 2019 · Ongoing
Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X,…
Medtronic Vascular Galway dba Medtronic Ireland
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular Galway DBA Medtronic Ireland · Parkmore Business Park West · Galway, N/A · N/A
Is this the product you have?
- Euphoria Rapid Exchange Balloon Dilatation Catheter
- Product Numbers
64 of 64 codes
EUP1506XEUP1510XEUP1512XEUP1515XEUP1520XEUP2006XEUP2010XEUP2012XEUP2015XEUP2020XEUP2025XEUP2030XEUP22506XEUP22510XEUP22512XEUP22515XEUP22520XEUP22525XEUP2506XEUP2510XEUP2512XEUP2515XEUP2520XEUP2525XEUP2530XEUP27506XEUP27510XEUP27512XEUP27515XEUP27520XEUP27525XEUP3006XEUP3010XEUP3012XEUP3015XEUP3020XEUP3025XEUP3030XEUP32506XEUP32510XEUP32512XEUP32515XEUP32520XEUP32525XEUP3506XEUP3510XEUP3512XEUP3515XEUP3520XEUP3525XEUP3530XEUP37506XEUP37510XEUP37512XEUP37515XEUP37520XEUP37525XEUP4006XEUP4010XEUP4012X
- Lot codes and dates
809 of 809 products
Products covered by this recall Model / number Barcodes Product as published EUP1506X00643169559813217238068 EUP1506X00643169618695217291131 EUP1506X00643169559813217354645 EUP1506X00643169979475217473721 EUP1506X00643169618695217473914 EUP1506X00643169979475217506615 EUP1506X00643169979475217576082 EUP1506X00643169559813217638054 EUP1506X00643169559813217833021 EUP1506X00643169979475217876349 EUP1510X00643169559820217225186 EUP1510X00643169559820217238070 EUP1510X00643169618633217262907 EUP1510X00643169559820217371289 EUP1510X00643169979413217396792 EUP1510X00643169979413217451079 EUP1510X00643169979413217473910 EUP1510X00643169618633217473911 EUP1510X00643169979413217518609 EUP1510X00643169559820217602408 - Amount recalled
- 53137 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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